Senior Regulatory Affairs Engineer (RA Operations)
Neko Health
Operations, Compliance / Regulatory
Europe
Posted on Oct 23, 2025
Are you ready to shape the future of medical technology? Neko Health is seeking a Senior Regulatory Affairs Engineerwho’s passionate about tackling complex regulatory strategies, enjoys working with cutting-edge medical devices, and thrives in a fast-paced, collaborativeand distributed environment.
We are looking for you that have extensive experience fromkeeping the regulatory affairs wheels spinning, keeping registrations of multiple devices in multiple markets current.
What You’ll Do
- Assign Product Codes and IDs: Define, review, assign, and keep up-to-date necessary codes (EMDN, GMDN, UDI, etc) for our medical devices.
- Own Product Registrations: Prepare, review and submit product registrations for applicable markets.
- Maintain Establishment Listings and Reporting: Obtain and maintain any establishment/operating licenses necessary for the activity as a medical device manufacturer, distributor or importer. Also, ensure reporting of requested information is performed in a timely manner (e.g. for ISO 14001, REACH, RoHS).
- Manage Legal Representatives: Ensure legal representatives are designated, necessary contracts are established,necessary internal processes are established.
- Drive Regulatory Intelligence: Monitorthe regulatory landscape tocatch new regulations, standards, trends and ensure that impact is analyzed and implemented to keep Neko Health at the forefront of compliance.
- Support Product Development: Advise on regulatory strategy throughout the product lifecycle with specific focus on device labeling for multiple markets.
- Empower Process Owners and Teams: Guide process owners and product teams to integrate regulatory requirements into our Quality Management System and deliver impactful training on compliance and regulatory topics.
What You Bring
- Education: BSc or MSc in law, medicine, pharmacy, engineering, or a related field.
- Experience: 4–5+ years in regulatory affairs or quality management for active medical devices and software as a medical device.
- Expertise: Deep knowledge of EU MDR, FDA CFR (Title 21 Subchapter H), UK MDR, ISO 13485, and more.
- Skills: Analytical, detail-oriented, and able to interpret complex regulations to provide risk-based recommendations.
- Communication: Excellent interpersonal and writing skills; able to engage and inspire both internal teams and external stakeholders.
- Mindset: Self-motivated, independent, and ready to take ownership in a dynamic, quality-focused environment.
- Languages: Fluent English required; Swedish proficiency is a plus.